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EC number: 470-740-0 | CAS number: 29721-79-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date: 29 October 2012 Experimental Completion Date: 15 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Water samples were taken from the control and the 100 mg/L test group (replicates R1 – R4 pooled) at 0 and 48 hours for quantitative analysis. All
samples were stored at approximately -20 °C prior to analysis.
Duplicate samples were taken and stored at approximately -20 °C for further analysis if necessary.
The method of analysis, recovery and test preparation analyses are described in the attached Appendix 5.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test concentration to be used in the definitive test was determined by a preliminary range-finding test.
In the range-finding test Daphnia magna were exposed to a series of nominal test concentrations of 0.10, 1.0, 10 and 100 mg/L. The test item was
dissolved directly in water.
An amount of test item (100 mg) was dissolved in reconstituted water and the volume adjusted to 1 liter to give the 100 mg/L test concentration.
Serial dilutions were prepared in reconstituted water from the 100 mg/L test concentration to give the remaining test concentrations of 0.10, 1.0 and 10 mg/L.
The prepared concentrations were inverted several times to ensure adequate mixing and homogeneity.
In the range-finding test 10 daphnids were placed in each test and control vessel and maintained in a temperature controlled room at 20 °C to 21 °C with a photoperiod of 16 hours light and 8 hours darkness for a period of 48 hours with 20 minute dawn and dusk transition periods. Each 250 mL test and control vessel contained 250 mL of test media and was covered to reduce evaporation. After 24 and 48 hours the number of immobilized
Daphnia magna were recorded.
The control group was maintained under identical conditions but not exposed to the test item.
A sample of each test concentration was taken for chemical analysis at 0 and 48 hours in order to determine the stability of the test item under test
conditions. All samples were stored at approximately -20 °C prior to analysis. Only concentrations within the range to be used for the definitive test were analyzed.
Definitive Test:
Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100 mg/L to confirm that at the maximum
concentration given in the OECD/EC Test Guidelines, no immobilization or adverse reactions to exposure were observed.
Experimental Preparation:
For the purpose of the definitive test the test item was dissolved directly in reconstituted water.
An amount of test item (100 mg) was dissolved in reconstituted water and the volume adjusted to 1 liter to give the 100 mg/L test concentration.
The prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
The concentration and stability of the test item in the test preparation was verified by chemical analysis at 0 and 48 hours (see attached Appendix 5).
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test Species:
The test was carried out using 1st instar Daphnia magna derived from in-house laboratory cultures.
Adult Daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium (see attached Appendix 2) in a temperature controlled room at approximately 20 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were approximately 25.5 hours old. These young were removed from the cultures and used for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study. The young were slightly older
than required in the GSP, however, this is considered not to have had an effect on the outcome of the study.
A positive control (Harlan Study Number: 41203341) used potassium dichromate as the reference item. Details of the positive control are given in
the attched Appendix 3.
Test Water:
Reconstituted water used for both the range-finding and definitive test is defined in the attached Appendix 4.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Not applicable
Test conditions
- Hardness:
- The reconstituted water had an approximate theoretical total hardness of 250 mg/l as CaCO3.
See attached Appendix 4. - Test temperature:
- The test vessels were covered to reduce evaporation and maintained in a temperature controlled room at 19 °C to 21 °C
The temperature was measured using a Hanna Instruments HI 93510 digital thermometer and recorded daily throughout the test. - pH:
- The reconstituted water had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCl and was aerated until the dissolved oxygen concentration was
approximately air-saturation value.
The pH was measured using a Hach HQ30d Flexi handheld meter at the start and termination of the test. - Dissolved oxygen:
- The reconstituted water was aerated until the dissolved oxygen concentration was approximately air-saturation value.
Dissolved oxygen concentrations were recorded at the start and termination of the test.
See Appendix 6 for results. - Salinity:
- freshwater used.
- Nominal and measured concentrations:
- Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100 mg/L to confirm that at the maximum
concentration given in the OECD/EC Test Guidelines, no immobilization or adverse reactions to exposure were observed. - Details on test conditions:
- Exposure Conditions
In the definitive test 250 mL glass jars containing approximately 200 mL of test preparation were used. At the start of the test 5 daphnids were
placed in each test and control vessel at random, in the test preparations. Four replicate test and control vessels were prepared. The test vessels
were then covered to reduce evaporation and maintained in a temperature controlled room at 19 °C to 21 °C with a photoperiod of 16 hours light
and 8 hours darkness with 20 minute dawn and dusk transition periods with a light intensity ranging from 542 to 571 lux. The daphnids were not
individually identified, received no food during exposure and the test vessels were not aerated.
The control group was maintained under identical conditions but not exposed to the test item.
The test preparations were not renewed during the exposure period. Any immobilization or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure. The criterion of effect used was that Daphnia were considered to be immobilized if they were unable to swim for approximately 15 seconds after gentle agitation.
Physico-Chemical Measurements
Water temperature and light intensity were recorded daily throughout the test. Dissolved oxygen concentrations and pH were recorded at the start
and termination of the test. The pH and dissolved oxygen concentration were measured using a Hach HQ30d Flexi handheld meter whilst the
temperature was measured using a Hanna Instruments HI 93510 digital thermometer.
Verification of Test Concentrations
Water samples were taken from the control and the 100 mg/L test group (replicates R1 – R4 pooled) at 0 and 48 hours for quantitative analysis.
All samples were stored at approximately -20 °C prior to analysis.
Duplicate samples were taken and stored at approximately -20 °C for further analysis if necessary.
The method of analysis, recovery and test preparation analyses are described in the attached Appendix 5.
Evaluation of Data
An estimate of the EC50 values was given by inspection of the immobilization data. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (see Appendix 3)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% Confidence limits (mg/L) 0.56 - 1.0
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.45 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% Confidence limits (mg/L) 0.42 - 0.48
- Details on results:
- RESULTS
Range-finding Test
Cumulative immobilization data from the exposure of Daphnia magna to the test item during the range-finding test are given in Table 1.
No immobilization was observed at the test concentrations of 0.10, 1.0, 10 and 100 mg/L.
Based on this information, a single test concentration of four replicates, of 100 mg/L was selected for the definitive test. This experimental design
conforms to a "Limit test" to confirm that at the maximum test concentration given in the OECD/EC Test Guidelines, no immobilization or adverse
reactions to exposure were observed.
Chemical analysis of the 100 mg/L test preparations at 0 and 48 hours (see Appendix 5) showed that measured concentrations of 111% to 100% of nominal were obtained respectively, indicating that the test item was stable under test conditions.
Definitive Test
Immobilization Data
Cumulative immobilization data from the exposure of Daphnia magna to the test item during the definitive test are given in Table 2.
There was no immobilization in 20 daphnids exposed to a test concentration of 100 mg/L for a period of 48 hours. Inspection of the immobilization data gave the following results:
Time (h) EC50 (mg/L)
24 >100
48 >100
The No Observed Effect Concentration after 24 and 48 hours exposure was 100 mg/L.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
Observations on Test Item Solubility
Throughout the duration of the test the test media was observed to be a clear colorless solution.
Physico-Chemical Measurements
The results of the physico-chemical measurements are given in the attached Appendix 6. Temperature was maintained at 19 °C to 21 °C throughout the test, while there were no treatment related differences for oxygen concentration or pH.
The oxygen concentration in some of the test vessels was observed to have an air saturation value (ASV) in excess of 100%. This was considered to be due to the presence of microscopic air bubbles in the media super-saturating the diluent and was considered not to have had an impact on the
outcome or integrity of the test as no adverse effects were observed in the control group.
Verification of Test Concentrations
Analysis of the test preparations at 0 and 48 hours (see attached Appendix 5) showed measured test concentrations of 102% and 96% of nominal
respectively were obtained and so it was considered justifiable to estimate the EC50 values in terms of the nominal test concentrations only. - Results with reference substance (positive control):
- Positive Control
A positive control (Harlan Study Number: 41203341) used potassium dichromate as the reference item at concentrations of 0.32, 0.56, 1.0, 1.8 and
3.2 mg/L.
Exposure conditions for the positive control were similar to those in the definitive test.
Analysis of the immobilization data by the geometric mean method at 24 hours and the trimmed Spearman-Karber method (Hamilton et al 1977 ) at 48 hours based on the nominal test concentrations gave the following results:
Time (h) EC50 (mg/L) 95% Confidence limits
(mg/L)
24 0.75 0.56 - 1.0
48 0.45 0.42 - 0.48
The No Observed Effect Concentrations after 24 and 48 hours were 0.56 and 0.32 mg/L respectively. The No Observed Effect Concentration is
based upon zero immobilization at this concentration.
The results from the positive control with potassium dichromate were within the normal range for this reference item.
- Reported statistics and error estimates:
- The 48-Hour EC50 for the test item to Daphnia magna based on nominal test concentrations was greater than 100 mg/L. The No Observed Effect
Concentration was 100 mg/L.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 102% to 96% of nominal value and so the results are based on nominal test concentrations only.
Analysis of the immobilization data by the geometric mean method at 24 hours and the trimmed Spearman-Karber method (Hamilton et al 1977 ) at 48 hours.
Any other information on results incl. tables
Tables
Table1 Cumulative Immobilization Data in the Range-finding Test
Nominal |
Cumulative Immobilized Daphnia |
|
24 Hours |
48 Hours |
|
Control |
0 |
0 |
0.10 |
0 |
0 |
1.0 |
0 |
0 |
10 |
0 |
0 |
100 |
0 |
0 |
Table 2 Cumulative Immobilization Data in the Definitive Test
Nominal |
Cumulative Immobilized Daphnia |
||||||
24 Hours |
48 Hours |
||||||
No. Per Replicate |
Total |
% |
No. Per Replicate |
Total |
% |
||
Control |
R1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
R2 |
0 |
0 |
||||
|
R3 |
0 |
0 |
||||
|
R4 |
0 |
0 |
||||
100 |
R1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
R2 |
0 |
0 |
||||
|
R3 |
0 |
0 |
||||
|
R4 |
0 |
0 |
R1– R4= Replicates 1 to 4
Analytical Tables
Table1 Preparation of Test Samples
Nominal |
Sample Volume |
Final Volume |
Sample Preparation Factor |
Final Nominal Concentration of Test Item |
|||||
[mg/L] |
[mL] |
[mL] |
F |
[mg/L] |
|||||
Control |
direct |
direct |
1 |
- |
|||||
100 |
10 |
100, then 5→ 100 |
200 |
0.50 |
- = Not Applicable
Table 2 Linearity Data
Concentration of Test Item |
Area |
[mg/L] |
[counts] |
0 |
0 |
0.0532 |
7.490 x 104 |
0.109 |
1.515 x 105 |
0.266 |
3.630 x 105 |
0.546 |
7.320 x 105 |
1.06 |
1.325 x 106 |
1.64 |
1.985 x 106 |
Table 3 Results for Range-Finding Samples
Time point |
Nominal Concentration of |
Measured Concentration
|
Sample Preparation Factor |
Determined Concentration of Test Item in Range-Finding Sample
|
% of Nominal Concentration |
[hours] |
[mg/L] |
[mg/L] |
|
[mg/L] |
[%] |
0 |
100 |
0.111 |
1 |
111 |
111 |
48 |
100 |
0.100 |
1 |
100 |
100 |
Table 4 Results for Spiked Recovery Samples
Nominal Concentration of |
Fortified Concentration of Test Item in the Spiked Sample
|
Measured Concentration of Test Item in the Sample Vial x |
Sample Preparation Factor
|
Determined Concentration of Test Item in the Spiked Sample
|
Analytical Recovery |
Precision (Relative Standard Deviation of Recovery) |
[mg/L] |
[mg/L] |
[mg/L] |
|
[mg/L] |
[%] |
[%] |
100 |
101 |
0.510 |
200 |
102 |
101 |
0.38 |
|
|
0.515 |
200 |
103 |
||
|
|
0.510 |
200 |
102 |
||
|
|
0.510 |
200 |
102 |
||
|
|
0.510 |
200 |
102 |
||
Acceptance Target |
|
|
|
80-120 |
<10 |
For reporting purposes, x has been calculated from c retrospectively.
Table 5 Results for Test Samples
Time point |
Nominal Concentration of Test Sample |
Measured Concentration
|
Sample Preparation Factor
|
Determined Concentration of Test Item in Test Sample
|
% of Nominal Concentration |
[hours] |
[mg/L] |
[mg/L] |
|
[mg/L] |
[%] |
0 |
Control |
<LOQ |
200 |
<LOQ |
- |
|
100 |
0.510 |
200 |
102 |
102 |
48 |
Control |
<LOQ |
200 |
<LOQ |
- |
|
100 |
0.478 |
200 |
95.6 |
96 |
LOQ = Limit of Quantitation
- = not applicable
For reporting purposes, x has been calculated from c retrospectively.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- CONCLUSION
The acute toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated and gave a 48-Hour EC50 of greater than
100 mg/L.
The No Observed Effect Concentration was 100 mg/L.
- Executive summary:
SUMMARY
Introduction
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.
Methods
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at a concentration of 100 mg/L for 48 hours at a temperature of 19°C to 21°C under static test conditions. Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.
Results
The 48-Hour EC50 for the test item to Daphnia magna based on nominal test concentrations was greater than 100 mg/L. The No Observed Effect Concentration was 100 mg/L.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 102% to 96% of nominal value and so the results are based on nominal test concentrations only.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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